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OpenTrials
Completed

NCT Number: NCT00934622

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 years or older;
  • need spherical correction between 10-30 Diopters (D);
  • corneal astigmatism less than 0.75D as measured by keratometry;
  • willing to sign an Informed Consent Form and complete all visits;
  • pupil dilation greater than 6mm;
  • expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion criteria

  • Women of childbearing potential;
  • irregular corneal astigmatism;
  • keratopathy/keratectasia;
  • cornea inflammation or edema;
  • cornea reshaping surgery;
  • corneal dystrophy;corneal transplant;
  • amblyopia;
  • glaucoma;
  • Retinal Pigment Epitheliopathy (RPE)/Macular changes;
  • proliferative diabetic retinopathy

Treatment and study plan

AcrySof® ReSTOR® Aspheric IOL

Device

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Primary outcomes

  1. Visual Acuity

    Time frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

    Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary outcomes

  1. Spectacle Independence

    Time frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery

    Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)

Important dates

Study start
2007
Primary completion
2009
First posted
Jul 8, 2009
Registry last updated
May 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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